度洛西汀与文拉法辛治疗抑郁与焦虑共病的开放性对照研究

An open and control study of duloxetine and venlafaxine in treatment of depression and anxiety comorbided disorder

目的比较度洛西汀与文拉法辛治疗抑郁与焦虑共病的临床效果及安全性。方法开放性研究共入组患者76例。度洛西汀组起始量为20mg·d-1,文拉法辛组起始量为50mg·d-1,于7～10d内分别加至60mg·d-1和200mg·d-1,bid,治疗8wk。采用汉密尔顿抑郁量表(HAMD)和汉密尔顿焦虑量表(HAMA)评定疗效,采用副反应量表(TESS)评定安全性。结果完成有效病例73例。度洛西汀组37例,年龄(52±s14)岁;文拉法辛组36例,年龄(47±13)岁。按符合方案集评定8wk末疗效,度洛西汀组有效率(减分率≥50%)为89%,文拉法辛组有效率为94%,2组无显著差异。2组HAMD、HAMA总分及因子治疗分在2、4、8wk末与治疗前比较,均有非常显著差异(P<0.01)。度洛西汀组的HAMD总分和认识障碍因子减分在治疗4wk和8wk末低于文拉法辛组(P<0.05,P<0.01),焦虑躯体化和迟缓因子减分分别在治疗2wk和8wk末低于文拉法辛组(P<0.05)。度洛西汀组的HAMA总分和躯体性焦虑因子减分在治疗2wk末大于文拉法辛组(P<0.05)。2组不良反应按安全数据集分析,度洛西汀组比文拉法辛组多见困倦嗜睡、口干和便秘(P<0.05,P<0.01),其他不良反应无显著差异(P>0.05)。结论度洛西汀与文拉法辛治疗抑郁与焦虑共病的疗效相当,不良反应相似。

AIM To compare the efficacy and safety of duloxetine and venlafaxine in the treatment of depression and anxiety comorbided disorder.METHODS Seventy-six patients with depression and anxiety comorbided disorder were chosen into the 8-week open-label study.The initial doses of duloxetine versus venlafaxine were 20 mg versus 50 mg bid daily,and increased to 60 mg versus 200 mg daily in 7-10 days.The efficacies were evaluated with Hamilton Depression Scale （HAMD） and Hamilton Anxiety Scale （HAMA） and the safety profiles were assessed with the Treatment Emergent Symptom Scale （TESS）.RESULTS Seventythree effective patients were completed,37 patients （age 52 ± s 14） in duloxetine group and 36 patients （age 47 ± 13） in venlafaxine group.Consistent with the Per-protocol sets at the end of 8 wk,the total effective rate was 89% in the duloxetine group （reduced rate ≥ 50%） and 94% in the duloxetine group,with no statistically significant difference.At 2,4,8 wk of the treatment,the total scores of HAMD and HAMA and factor scores of two groups were both significantly decreased （P 0.01）.The reduction of the total scores of HAMD and factor scores of cognitive impairment factor in the duloxetine group were lower than that of the venlafaxine group at the end of 4 wk and 8 wk （P 0.05,P 0.01）,while the reduction of factor scores of psychosomatic anxiety and retardation were statistically lower than that of the venlafaxine group at the end of 2,8 wk （P 0.05）,respectively.The total scores of HAMA and factor scores of somatic anxiety were higher than that of the venlafaxine group at the end of 2 wk （P 0.05）.According to the Safety Analysis Set,the incidence of sleepy drowsiness,dry mouth,and constipation in duloxetine group were significantly higher than that in venlafaxine group （P 0.05,P 0.01） and other adverse reactions had no significant difference （P 0.05）.CONCLUSION Duloxetine and venlafaxine possesse similiar effectiveness and safety in the treatment of depression and anxiety comorbided disorder.